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 Séripharm
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Séripharm, founded in 1987 as a Product and Process Development Company aimed at synthesizing and purifying anti cancer API, is located in the close vicinity of the Le Mans University on a 20,000 m2 site.
Fifteen years of industrial experience and know how have given Séripharm a strong background and expertise in the process development and production of numerous High Potent Active Pharmaceutical Ingredients (HPAI) such as Cytotoxics. |
Séripharm offers early-stage up to industrial custom manufacturing services mainly focused on cytotoxics and highly potent products (HPAI).
Séripharm offers access to a wide range of technologies in its FDA’s inspected facility.
Séripharm has the ability to combine techniques such as extraction, synthesis and semi-synthesis, preparative chromatography, crystallization and containments for HPAI up to Class 5 (OEL < 0.1-5 µg/m3) at any scale.
 Services
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- Process development and scale-up
- Production of preclinical and clinical batches (cGMP or not)
- Multi year industrial production for NDA or ANDA approved API
- Preparation of reference compounds, analytical standards, metabolites…
- Analytical methods development
- Stability Studies
- Processes and methods validations
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Equipment
3 Kilolabs and 2 Industrial Suites
- Doubled jacketed glass reactors from 1 to 400 litres
(- 60°C to 120°C)
- Batch evaporators (20 to 50 l.) and falling film evaporators (up to 1m2)
- Automated preparative HPLC’s (i.d. 50 to 300 mm)
- Filter-dryer 0,03m2 with associated glove-boxe (Air Cleanliness Class 10,000)
- Confined spin dryers (up to i.d. 500mm)
- Lab. scale freeze dryer
- Isolators and gloves boxes for handling highly potent substances (Air cleanliness Class 10.000)
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Analytical resources
- HPLC, GC, KF, IRFT, UV, DSC, LC-MS
- NHR, XRPD
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 Synthesis sites |
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